FDA.reportPublic FDA data

Bayer HealthCare, LLC

Matched from indexed company URL: BAYER CORP.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
22432522243252Bayer HealthCare, LLC1N2026-01-0136 Columbia Rd Morristown NJ US 07960
22489033000206585BAYER HEALTHCARE LLC, CONSUMER CARE1Y2026-01-0136 Columbia Rd MORRISTOWN NJ US 07960
25203132520313Bayer Medical Care Inc.1N2026-01-011 Bayer Drive INDIANOLA PA US 15051
30040561593004056159Bayer Medical Care Inc.1N2026-01-01625 Alpha Dr Pittsburgh PA US 15238
30067913313006791331Bayer Medical Care Inc.1N2026-01-01150 Victory Road Saxonburg PA US 16056
30113345553011334555Bayer Medical SRL1N2026-01-01Block B Lot 1 Metro Park Barreal de Heredia CR 6-3060
30124691823012469182Bayer Medical Care B.V.1N2026-01-01Avenue Ceramique 27 Maastricht Limburg NL 6221 KV
19109531910953BAYER HEALTHCARE LLC1N2020-04-2512707 SHAWNEE MISSION PKWY Shawnee Mission KS US 66216
30063331283006333128BAYERISCHE MOTOREN WERKE AG1N2020-04-25Petuelring 130 Munchen Bayern DE 80809
30134684113013468411BAYER FEINWERK GMBH & CO. KG1N2020-04-25Max-Planck-Strasse 49 Villingen-Schwenningen Baden-Wurttemberg DE 78052

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00616258007243200mL Sterile Disposable Qwik-Fit Syringe & QFT - """Envision, Vistron, MCT- 200 ml syringe with quick fill tube(ASSY,PKG,SYR,200ML W/QFT,ODYSSY,MC,JA)(84197084)"""+1(800)633-7231ricustomercomplaints@bayer.com
00616258007526200mL Sterile Disposable Qwik-Fit Syringe & QFT - Envision, Vistron, MCT- 200 ml syringe with quick fill tube(CT - 200ML ENV/VIST SYRINGE KIT W/QFT)(60729121)+1(800)633-7231ricustomercomplaints@bayer.com
00616258024325MEDRAD® MRXperion Sterile Disposable MRI Kit - MRXP,KIT,SYR,MRI,65/115ML,MC,CORE (87632016)+1 800-633-7231ricustomercomplaints@bayer.com
00616258025094MEDRAD® MRXperion MR Injection System - SYSTEM,INJECTOR,MRXPERION,CORE,LR (87838420)+1 800-633-7231ricustomercomplaints@bayer.com
00616258026206MEDRAD® MRXperion MR Injection System Handswitch - ASSY,KIT,HAND SWITCH,LR,MRXP (88311515)+1(800)633-7231ricustomercomplaints@bayer.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1887361802181199P020014ESSURE SYSTEMHHS2002-11-04
382511344283833K984418UNIVERSAL ADJUSTABLE T-RAIL TABLE BRACKETDXT1999-03-11
382511200476669K982814MEDRAD VISTRON CT INJECTOR SYSTEMDXT1998-10-09
382511538179113K980417MEDRAD DISPOSABLE MRI KIT W/CHECK VALVE MODELSQK 65V, MEDRAD MRI INTEGRAL T WITH CHECK VALVE MODEL SIT 96VLNH1998-05-04
77431781752200K944983MEDRAD COUNTERPOISE SYSTEMJAK1994-11-29
382511781752200K944983MEDRAD COUNTERPOISE SYSTEMJAK1994-11-29
382511453694574K935668MEDRAD SPECTRIS MR INJECTORDXT1995-09-25
382511756560956K934086MEDRAD ENVISION CT INJECTOR AND QWIK FIT SYRINGEDXT1995-06-15
382511429888083K924116MEDRAD MCT, MCT PLUS INJECTOR/MEDRAD FRONT LOADDXT1993-01-21
77431329681580K903390MEDRAD MARK V-PLUS INJECTORDXT1990-09-26
382511329681580K903390MEDRAD MARK V-PLUS INJECTORDXT1990-09-26
77431276790125K870243BURNETT TMJ APPLIANCEEAG1987-02-24
382511276790125K870243BURNETT TMJ APPLIANCEEAG1987-02-24
382511455622968K831188CONNECTOR TUBEDOY1983-05-09
77431386746254K822536MARK VDXT1982-09-28
382511386746254K822536MARK VDXT1982-09-28
382511402979606K810924MEDRAD HIGH PRESSURE CONECTING TUBEDWE1981-04-17
382511316381139K800823QUICK FILLDXT1980-04-29
77431099162770K252891MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2)DXT2026-02-13
382511099162770K252891MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2)DXT2026-02-13
3456021154903956K250893Ball Joint Guide Array (66295)HAW2025-09-04
382511387724812K241849MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2)IZQ2024-11-05
382511648970145K200280MEDRAD Imaging Bulk Package Transfer SpikePQH2020-07-30
77432033185571K182276MEDRAD MRXperion MR Injection System and MR Injection System Syringe KitDXT2018-11-01
382512033185571K182276MEDRAD MRXperion MR Injection System and MR Injection System Syringe KitDXT2018-11-01
77432024714756K182273MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CTDXT2018-11-01
382512024714756K182273MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CTDXT2018-11-01
723562024714756K182273MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CTDXT2018-11-01
382511595211460K173913MEDRAD® Imaging Bulk Package Transfer SetPQH2018-05-04
77431161549562K173773MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CTDXT2018-08-17
382511161549562K173773MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CTDXT2018-08-17
723561161549562K173773MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CTDXT2018-08-17
596651304371515K152852ALEVE Direct Therapy (ALEVE Direct Therapy TENS device)NUH2015-12-22
77431899207769K143538MRXperion MR Injection System, MRXperion MR Injection System Syringe KitDXT2015-08-14
382511899207769K143538MRXperion MR Injection System, MRXperion MR Injection System Syringe KitDXT2015-08-14
77432013662414K132928MEDRAD MARK 7 ARTERION INJECTION SYSTEM / SYRINGE, TWIST & GO SYRINGEDXT2014-01-23
382512013662414K132928MEDRAD MARK 7 ARTERION INJECTION SYSTEM / SYRINGE, TWIST & GO SYRINGEDXT2014-01-23
382511100513449K131517MEDRAD TWIST & GO HIGH PRESSURE CONNECTOR TUBINGFPK2013-08-02
77431173632912K113133MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM), (TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION ARTERION SYRINGEDXT2011-12-15
382511173632912K113133MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM), (TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION ARTERION SYRINGEDXT2011-12-15
77431684613119K112086MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM / TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION SYRINGEDXT2011-10-14
382511684613119K112086MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM / TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION SYRINGEDXT2011-10-14
77431275937558K100798MEDRAD INTEGO PET INFUSION SYSTEM, SOURCE ADMINISTRATION SET, PATIENT ADMINSTRATIN SET MODEL INT SYS 100, INT CSS, INT CFRN2010-06-23
382511275937558K100798MEDRAD INTEGO PET INFUSION SYSTEM, SOURCE ADMINISTRATION SET, PATIENT ADMINSTRATIN SET MODEL INT SYS 100, INT CSS, INT CFRN2010-06-23
382511455367923K083723A6 LUER ACCESS DEVICEFPA2009-06-05
77431007638468K082905MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T CARDIACDXT2009-01-12
382511007638468K082905MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T CARDIACDXT2009-01-12
723561007638468K082905MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T CARDIACDXT2009-01-12
77431462561168K082458P3T ABDOMENJAK2008-10-17
382511462561168K082458P3T ABDOMENJAK2008-10-17
77431576350984K080297MEDRAD INTEGO PET INFUSION SYSTEMFRN2008-06-17
382511576350984K080297MEDRAD INTEGO PET INFUSION SYSTEMFRN2008-06-17
382511973235202K073051MEDRAD CONTINUUM MR INFUSION SYSTEM WITH WIRELESS REMOTE ACCESSORYFRN2008-05-30
77431037544538K072886MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3TDXT2007-12-21
382511037544538K072886MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3TDXT2007-12-21
77431558272264K063090MEDRAD STELLANT CT INJECTOR SYSTEM WITH XDS ACCESSORYIZQ2007-03-27
382511558272264K063090MEDRAD STELLANT CT INJECTOR SYSTEM WITH XDS ACCESSORYIZQ2007-03-27
2243601070563920K061180KSEA ROTOCUT G1 ELECTROMECHANICAL MORCELLATORGCJ2006-07-27
596651460791089K052259DR. SCHOLL'S DUAL ACTION FREEZE AWAY WART REMOVER, MODEL 40406GEH2005-12-14
382511881646712K051499INTRAVASCULAR ADMINISTRATION SET AND EXTENSION SETFPA2005-06-22
77431784581612K050456MEDRAD AVANTA FLUID MANAGEMENT INJECTION SYSTEMDXT2005-06-17
382511784581612K050456MEDRAD AVANTA FLUID MANAGEMENT INJECTION SYSTEMDXT2005-06-17
77431076822353K042784MEDRAD SPECTRIS SOLARIS EP MR INJECTOR SYSTEMDXT2004-12-10
382511076822353K042784MEDRAD SPECTRIS SOLARIS EP MR INJECTOR SYSTEMDXT2004-12-10
1887361463413124K042784MEDRAD SPECTRIS SOLARIS EP MR INJECTOR SYSTEMDXT2004-12-10
77431308265950K0425698600 VITAL SIGNS MONITORMWI2004-09-29
382511308265950K0425698600 VITAL SIGNS MONITORMWI2004-09-29
77431599035822K033881MEDRAD STELLANT CT INJECTOR SYSTEM WITH IMAGING SYSTEM INTERFACE MODULEDXT2004-03-02
382511599035822K033881MEDRAD STELLANT CT INJECTOR SYSTEM WITH IMAGING SYSTEM INTERFACE MODULEDXT2004-03-02
382511214417884K031808MEDRAD SWABBABLE VALVE TRANSFER SETFPK2003-07-11
596651671315556K031697DR. SCHOLL'S FREEZE AWAY WART REMOVER, MODEL 40226GEH2003-08-29
382511496343821K031483MEDRAD MANUAL SYRINGE LOADERDXT2003-08-01
77431782692340K023183MEDRAD STELLANT CT INJECTOR SYSTEMDXT2003-01-10
382511782692340K023183MEDRAD STELLANT CT INJECTOR SYSTEMDXT2003-01-10
723561782692340K023183MEDRAD STELLANT CT INJECTOR SYSTEMDXT2003-01-10
382511222150131K022431MEDRAD TRANSFER SETFPK2002-09-05
382511704199121K013815MEDRAD QWIK-FIT SYRINGEDXT2001-12-13
382511830496072K012950MODIFICATION TO: MEDRAD SPECTRIS SOLARIS MR INJECTOR SYSTEMDXT2001-10-04
596651129076330
596651509386015
2008601509386015
596651657124756
596651749212935
77431948307194
382511948307194
1494392062078213
382511027806441
382511054412563
2352791054412563
2352791076822353
77431327165487
77431387724812
2352791387724812
2352791455622968
382511469602208
382511498936185
77431624143442
382511624143442
596651917433349
596651932198061
382511950608922
77431994134198
1887362019301403

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DXT472026-02-13
FRN52010-06-23
JAK42008-10-17
IZQ32024-11-05
FPK32013-08-02
PQH22020-07-30
FPA22009-06-05
GEH22005-12-14
MWI22004-09-29
HHS22002-11-04
EAG21987-02-24
HAW12025-09-04
NUH12015-12-22
GCJ12006-07-27
LNH11998-05-04
DOY11983-05-09
DWE11981-04-17

NDC#

Kovaltry

Bayer HealthCare LLC

Antihemophilic Factor (Recombinant)

Kovaltry

Bayer HealthCare LLC

Antihemophilic Factor (Recombinant)

Kovaltry

Bayer HealthCare LLC

Antihemophilic Factor (Recombinant)

Kovaltry

Bayer HealthCare LLC

Antihemophilic Factor (Recombinant)

Kovaltry

Bayer HealthCare LLC

Antihemophilic Factor (Recombinant)

Jivi

Bayer HealthCare LLC

Antihemophilic Factor (Recombinant) Pegylated-aucl

Jivi

Bayer HealthCare LLC

Antihemophilic Factor (Recombinant) Pegylated-aucl

Jivi

Bayer HealthCare LLC

Antihemophilic Factor (Recombinant) Pegylated-aucl

Jivi

Bayer HealthCare LLC

Antihemophilic Factor (Recombinant) Pegylated-aucl

Jivi

Bayer HealthCare LLC

Antihemophilic Factor (Recombinant) Pegylated-aucl

AleveX

Bayer HealthCare LLC

camphor and menthol

AleveX

Bayer HealthCare LLC

camphor and menthol

AleveX

Bayer HealthCare LLC

camphor and menthol

200 records. Showing 1-40. Next

PMA#

ESSURE

2013-10-30

BAYER PHARMA AG

56 records. Showing 1-40. Next

PMN#

184 records. Showing 1-40. Next

Applications#

135 records. Showing 1-40. Next

GUDID#

80 records. Showing 1-40. Next